Cleared Traditional

K781436 - DELTA TEST ASSAY, HDL CHLORESTEROL (FDA 510(k) Clearance)

K781436 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device

Oct 1978

Decision

46d

Days

—

Risk

K781436 is an FDA 510(k) clearance for the DELTA TEST ASSAY, HDL CHLORESTEROL..

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 3, 1978, 46 days after receiving the submission on August 18, 1978.

This device falls under the Chemistry FDA review panel.

Submission Details

510(k) Number	K781436 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 1978
Decision Date	October 03, 1978
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	—
Device Class	—